Back to resultsA New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
GM-CT-01
5-Fluorouracil, Leukovorin, bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, DAVANAT, colon cancer, 5-FU
Eligibility Criteria
Inclusion Criteria:
- 18 years or older.
- Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
- Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
- Presence of at least 1 measurable lesion,
- Have a life expectancy of at least 4 months.
- Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.
Exclusion Criteria:
- Central nervous system metastasis.
- Bony metastasis as the sole metastasis.
- Received any prior first-line chemotherapy for colorectal cancer.
- Previously exposed to DAVANAT® or Avastin®.
- Known or clinically suspected infection with HIV.
- Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
- History of drug or alcohol dependence in the past 3 years.
- Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Sites / Locations
- Rambam Medical Center
- Kaplan MC
- Sheba MC
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GM-CT-01
Arm Description
Outcomes
Primary Outcome Measures
Primary Outcomes: Assess the efficacy and safety of GM-CT-01 administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC.
To assess the clinical benefit of a regimen of GM-CT-01/5-FU, LV plus Avastin® when administered intravenously as a first-line treatment to patients with Stage III or IV ,advanced or metastatic CRC. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete response [CR]) plus partial response [PR]). Tumor response will be assessed following Response Evaluation by RECIST guidelines.
Secondary Outcome Measures
To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.
Assess safety of regimen and also patient reported outcomes using a Quality of Life (QoL) instrument.
Explore progression-free survival (PFS) and survival
To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.
Full Information
NCT ID
NCT00388700
First Posted
October 13, 2006
Last Updated
February 13, 2018
Sponsor
Galectin Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00388700
Brief Title
A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
Official Title
Open-Label, Phase 2 Study of GM-CT-01 When Added to a Regimen of Leucovorin, 5-FU, and Avastin as First Line Treatment for Locally Advanced, Unresectable or Metastatic Colorectal Cancer in Subjects Unable to Tolerate Intensive Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Financing and re-organization
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galectin Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is beneficial in treating colorectal cancer in patients unable to tolerate intensive chemotherapy.
Detailed Description
This is a Phase II, multi-center study of DAVANAT which has been shown to increase the anti-tumor activity of 5-FU in mice. 5-FU is a chemotherapy drug commonly used to treat tumors. A Phase I study of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, DAVANAT, colon cancer, 5-FU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GM-CT-01
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GM-CT-01
Other Intervention Name(s)
DAVANAT
Intervention Description
On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil, Leukovorin, bevacizumab
Other Intervention Name(s)
5-FU, LV, Avastin®
Intervention Description
On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.
Primary Outcome Measure Information:
Title
Primary Outcomes: Assess the efficacy and safety of GM-CT-01 administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC.
Description
To assess the clinical benefit of a regimen of GM-CT-01/5-FU, LV plus Avastin® when administered intravenously as a first-line treatment to patients with Stage III or IV ,advanced or metastatic CRC. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete response [CR]) plus partial response [PR]). Tumor response will be assessed following Response Evaluation by RECIST guidelines.
Time Frame
When 17 evaluable patients will complete the study
Secondary Outcome Measure Information:
Title
To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.
Description
Assess safety of regimen and also patient reported outcomes using a Quality of Life (QoL) instrument.
Time Frame
Throughout the study and when 17 evaluable patients will when complete the study
Title
Explore progression-free survival (PFS) and survival
Description
To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.
Time Frame
When at least 17 evaluable patients complete the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older.
Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
Presence of at least 1 measurable lesion,
Have a life expectancy of at least 4 months.
Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.
Exclusion Criteria:
Central nervous system metastasis.
Bony metastasis as the sole metastasis.
Received any prior first-line chemotherapy for colorectal cancer.
Previously exposed to DAVANAT® or Avastin®.
Known or clinically suspected infection with HIV.
Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
History of drug or alcohol dependence in the past 3 years.
Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Kaplan MC
City
Rechovot
Country
Israel
Facility Name
Sheba MC
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
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